Tecfen Medical 2.2mm Slit Knife ophthalmic device sterility recall
Tecfen Medical is recalling its 2.2mm Slit Knife (Model QKN2261) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for eye surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterile surgical device with a sterility assurance defect, creating a potential risk of infection or harm during ophthalmic surgery. No reported illnesses or injuries are stated in the source.
Plain-English summary
Tecfen Medical is recalling the 2.2mm Slit Knife, Angled (Model QKN2261), an ophthalmic knife designed to create precise incisions for controlled entry into the eye. The recall is due to sterility assurance issues with the device, which is supplied as a sterile, single-unit packaged instrument.
The recalled lot (Lot number ZGY24080201-02, manufactured November 21, 2024, with expiration November 20, 2027) totals 92 units. Distribution was nationwide in Connecticut and Minnesota, with additional distribution to the Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Bangladesh, Brazil, and Israel.
If you have received this product, contact Tecfen Medical for instructions on return or replacement. Patients who have undergone procedures with this device should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
- Manufacturer
- Tecfen Medical
- Hazard
- sterility-defect
- infection-risk
Distribution
Distributed nationwide across the United States.
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